The FDA has placed a phase 1/2 trial of Passage Bio’s GM1 gangliosidosis gene therapy PBGM01 on clinical hold pending further assessment of the risks associated with its delivery device, delaying the start of the study until around the end of the year.
Passage Bio, a James Wilson-founded gene therapy startup, raised two private megarounds last year and completed a $216 million IPO in February, giving it the means to advance a pipeline led by its GM1 prospect into the clinic. That plan advanced in June when Passage Bio filed an IND for PBGM01 but has now hit a snag.
